NCT03498495

Brief Summary

SMART is an interactive web-based program that will allow youth with mild traumatic brain injuries (mTBI) to monitor their symptoms and receive education on problem-solving and coping strategies. This study will evaluate the effectiveness of SMART as a means of improving symptom-management, coping skills, and general well-being during recovery from mTBI. Half of participants will receive the SMART intervention, while half will receive usual care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 12, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

July 10, 2023

Status Verified

July 1, 2023

Enrollment Period

1.3 years

First QC Date

April 4, 2018

Last Update Submit

July 6, 2023

Conditions

Brain Injury Traumatic Mild

Outcome Measures

Primary Outcomes (1)

  • Change in quality of life, as measured by the Pediatric Quality of Life Inventory (PedsQL)

    The PedsQL includes 23 items measuring physical, emotional, social, and school functioning.

    From baseline to 4 weeks post-injury

Secondary Outcomes (4)

  • Change in coping strategies, as measured by the Coping Strategies Inventory (CSI-S: Short Form)

    From baseline to 4 weeks post-injury

  • Change in self-efficacy for symptom management, as measured by the Self-Efficacy Scale (S-eS)

    From baseline to 4 weeks post-injury

  • Change in general functioning, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS)

    From baseline to 4 weeks post-injury

  • Change in health and behavioral symptoms, as measured by the Health and Behavior Inventory (HBI)

    From baseline to 4 weeks post-injury

Study Arms (2)

SMART Intervention

EXPERIMENTAL
Behavioral: Self-Monitoring Activity-restriction and Relaxation Training (SMART)

Usual Care

NO INTERVENTION

Interventions

Self-Monitoring Activity-restriction and Relaxation Training (SMART)BEHAVIORAL

SMART integrates real-time self-monitoring of symptoms and activities with interactive modules designed to increase self-efficacy through psychoeducation and training in problem solving/problem-focused coping strategies.

SMART Intervention

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years old
  • Sustained mTBI within the past week

You may not qualify if:

  • Patient and/or family do not speak and read English
  • Patient and/or family do not have Internet access
  • Patient experiencing more severe brain injury (Glasgow coma score \<13)
  • Patient with more than one moderate extracranial injury
  • Patients with non-mTBI reasons for altered mental status
  • Patients with severe pre-existing neurologic or cognitive disorders or other disorders that may impair ability to participate in the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • Wade SL, Sidol C, Babcock L, Schmidt M, Kurowski B, Cassedy A, Zhang N. Findings from a Randomized Controlled Trial of SMART: An EHealth Intervention for Mild Traumatic Brain Injury. J Pediatr Psychol. 2023 Mar 20;48(3):241-253. doi: 10.1093/jpepsy/jsac086.

    PMID: 36565462DERIVED

MeSH Terms

Conditions

Brain Concussion

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Lynn Babcock, M.D.

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 13, 2018

Study Start

May 12, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

July 10, 2023

Record last verified: 2023-07

Locations

US(1)